This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 versus tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission with first-line chemotherapy.

Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator. [ Time Frame: PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of INCB024360 by adverse event assessment. [ Time Frame: Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest. ] [ Designated as safety issue: Yes ]

Duration of overall survival. [ Time Frame: Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest. ] [ Designated as safety issue: No ]

Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.

Drug: INCB024360

Active Comparator: Tamoxifen

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Drug: tamoxifen

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects who have received first-line chemotherapy, which must have been a platinum-containing regimen.

Subjects who received maintenance paclitaxel or, bevacizumab, or alternative maintenance therapy (e.g. vaccines) are eligible for enrollment provided they have discontinued therapy at least 4 weeks for prior taxane and, at least 8 weeks for bevacizumab, or received medical monitor approval for time lapse from alternative maintenance therapy prior to randomization and recovered from toxicities to less than Grade 2.

Subject must be currently in remission by clinical and radiological criteria (Response Evaluation Criteria for Solid Tumors [RECIST 1.1]).

a. If a PET scan or high-resolution CT scan is performed and demonstrates new disease </= 1 cm, these subjects would be eligible.

Prior to the first-line regimen, CA 125 must have been elevated at first diagnosis, must have normalized with the first-line therapy/regimen, and is currently elevated:

a. CA 125 elevation is defined as 2 consecutive measurements that are both above the Upper Limit of Normal (ULN) at least 42 weeks apart, with the second measure showing further increases from the first measurement

If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.

CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at least 1 week apart (UK ONLY REQUIREMENT).

CA 125 elevation must be at least 3 months from completion of first-line platinum-containing regimen.

Documentation of at least 1 normal CA 125 level at approximately 3 months during or following first line therapy is required.

Subjects with any evidence of new disease (> 1 cm) including new ascites as confirmed by imaging.

Any other prior antitumor systemic therapy except for first-line chemotherapy associated with previous CA 125 normalization or maintenance paclitaxel, bevacizumab, or alternative maintenance therapy as approved by the medical monitor.

Subjects with prior radiotherapy within 3 months of randomization and have not recovered from all radiotherapy-related toxicities, who have received radiation therapy to the chest within 3 months of randomization, or who have a history or radiation pneumonitis.

Subjects receiving monoamine oxidase inhibitors (MAOIs) within the 21 days prior to screening; subjects who have ever had Serotonin Syndrome (SS) after receiving 1 or more serotonergic drugs.

Subjects for whom tamoxifen therapy is contraindicated.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01685255